Patent foramen ovale (PFO) closure was recommended for some stroke survivors in updated guidance from the American Academy of Neurology (AAN).
"In patients younger than 60 years with a PFO and an embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (reduction of stroke recurrence) and risks (procedural complication and atrial fibrillation [Afib])," according to the practice advisory .
This recommendation was backed by level C evidence, said guideline authors led by Steven Messé, MD, of the University of Pennsylvania School of Medicine in Philadelphia.
The new AAN guideline took into account recent randomized trials comparing PFO closure against medical therapy alone, as well as FDA approval of the Amplatzer PFO Occluder and the Gore Cardioform Septal Occluder.
The prior 2016 AAN practice advisory had concluded there was not enough evidence to support routine PFO closure to prevent a second stroke.
"It's important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems," said Messé in a press release.
"However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone," he reasoned.
The updated guideline recommended that candidates for PFO closure undergo thorough evaluation to rule out alternative mechanisms of stroke (level B). Those at higher risk of an alternative mechanism should not be routinely recommended PFO closure (level B).
Stroke survivors who wish to go on medical therapy without PFO closure may be prescribed either antiplatelet medication or anticoagulation (level C).
Questions that require further research in PFO closure include how direct oral anticoagulants (DOACs) stack up with PFO closure in younger patients and comparison of DOACs with antiplatelets in older patients and younger patients not interested in closure, Messé and colleagues suggested.
"Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks and the effect of residual shunts and incidence of Afib," they added.
The practice advisory was endorsed by the Society for Cardiovascular Angiography, the American Heart Association/American Stroke Association, and the European Academy of Neurology.
Disclosures
The practice advisory was developed with financial support from the AAN.
Guideline authors disclosed various ties to industry.
Primary Source
Neurology
Messé SR, et al "Practice advisory update summary: patent foramen ovale and secondary stroke prevention" Neurology 2020; DOI: 10.1212/WNL.0000000000009443.